Trial Outcomes & Findings for Ketamine to Prevent PPD After Cesarean (NCT NCT04227704)
NCT ID: NCT04227704
Last Updated: 2023-01-26
Results Overview
Establish a sufficient burden of disease (\>10%) in our population to warrant a full RCT
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
42 days postpartum
Results posted on
2023-01-26
Participant Flow
2 participants withdrew from the study; only 23 had data to report.
Participant milestones
| Measure |
Control
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Overall Study
due to anesthesia being changed to general anesthesia
|
0
|
1
|
0
|
|
Overall Study
due to C/S being cancelled
|
1
|
0
|
0
|
Baseline Characteristics
Ketamine to Prevent PPD After Cesarean
Baseline characteristics by cohort
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 6.53 • n=99 Participants
|
32.6 years
STANDARD_DEVIATION 0.95 • n=107 Participants
|
30.1 years
STANDARD_DEVIATION 4.30 • n=206 Participants
|
31.8 years
STANDARD_DEVIATION 4.43 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
BMI
|
32.8 kg/m^2
STANDARD_DEVIATION 7.84 • n=99 Participants
|
41.1 kg/m^2
STANDARD_DEVIATION 12.0 • n=107 Participants
|
36.0 kg/m^2
STANDARD_DEVIATION 6.06 • n=206 Participants
|
36.8 kg/m^2
STANDARD_DEVIATION 9.30 • n=7 Participants
|
|
Gestational age (weeks)
|
37.5 weeks
STANDARD_DEVIATION .76 • n=99 Participants
|
38.7 weeks
STANDARD_DEVIATION 1.11 • n=107 Participants
|
38.0 weeks
STANDARD_DEVIATION 1.11 • n=206 Participants
|
38.1 weeks
STANDARD_DEVIATION 1.08 • n=7 Participants
|
|
American Society of Anesthesiologists' (ASA) physical status classification system
ASA II
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
American Society of Anesthesiologists' (ASA) physical status classification system
ASA III
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Insurance status
Insured
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Insurance status
Uninsured
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Pre-operative Anxiety, Depression and Psychosocial Stress screening
Anxiety (GAD-7)
|
7.29 units on a scale
STANDARD_DEVIATION 2.93 • n=99 Participants
|
6.13 units on a scale
STANDARD_DEVIATION 8.20 • n=107 Participants
|
6.25 units on a scale
STANDARD_DEVIATION 5.55 • n=206 Participants
|
6.52 units on a scale
STANDARD_DEVIATION 5.81 • n=7 Participants
|
|
Pre-operative Anxiety, Depression and Psychosocial Stress screening
Depression (EPDS)
|
8.29 units on a scale
STANDARD_DEVIATION 4.72 • n=99 Participants
|
6.25 units on a scale
STANDARD_DEVIATION 6.27 • n=107 Participants
|
5 units on a scale
STANDARD_DEVIATION 4.78 • n=206 Participants
|
6.43 units on a scale
STANDARD_DEVIATION 5.26 • n=7 Participants
|
|
Pre-operative Anxiety, Depression and Psychosocial Stress screening
Psychosocial stress (ANRQ)
|
26.3 units on a scale
STANDARD_DEVIATION 13.0 • n=99 Participants
|
17 units on a scale
STANDARD_DEVIATION 14.4 • n=107 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 9.25 • n=206 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 12.8 • n=7 Participants
|
|
Psychiatric history
Any psychiatric history
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Psychiatric history
PPD
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Psychiatric history
MDD
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Psychiatric history
Anxiety
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Psychiatric history
Mood disorder
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Psychiatric history
Personality disorder
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Psychiatric history
Psychotic disorder
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Psychiatric history
Premenstrual syndrome
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Psychiatric history
Premenstrual dysmorphic disorder
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Psychiatric history
Panic disorder
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Psychiatric history
Bipolar affective disorder
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Psychiatric history
Obsessive compulsive disorder
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 42 days postpartumEstablish a sufficient burden of disease (\>10%) in our population to warrant a full RCT
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30
|
4 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 9 monthsEstablish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population Twenty-five (20.7%) out of 121 women who were approached consented to participation. 2 were withdrawn with 23 completing participation.
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Percentage of Eligible Patients Consenting to Participation
|
7 Participants
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 9 monthsEnsure that the design of assessments and data collection make it possible to achieve a complete dataset in \>90% of participants
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Percentage of Patients With a Complete Dataset
|
3 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 9 monthsAscertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by \>10% of participants in that study arm.
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Number of Patients in Study Arms Experiencing One or More Severe Side Effects
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursIntraoperative supplementary analgesia in morphine milligram equivalents
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Dose of Opiate Analgesics Administered
|
88.6 Morphine Milligram Equivalents
Standard Deviation 35.6
|
68.4 Morphine Milligram Equivalents
Standard Deviation 63.7
|
67.0 Morphine Milligram Equivalents
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursIntraoperative supplementary analgesia
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Dose of Ketorolac Administered (mg)
|
30 mg
Standard Deviation 0
|
30 mg
Standard Deviation 0
|
30 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursPrevalence of participants with intraoperative hypotension of a systolic BP of less than 90
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Prevalence of Intraoperative Hypotension
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursReported maximal level of intraoperative pain on the numerical rating scale 0 - 10, where 0 is no pain and 10 is the worst pain imaginable
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Maximum Intraoperative Pain (NRS)
|
3 Rating Score
Interval 1.0 to 5.0
|
5 Rating Score
Interval 1.0 to 10.0
|
1.5 Rating Score
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Intraoperative and 2 and 6 hours postoperativelyIncidence and severity (mild, moderate or severe) of nausea, vomiting, pruritus, dizziness, sedation, shivering, anxiety, euphoria, hallucinations, amnesia, blurred vision, diplopia, nystagmus
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Adverse Effects
Moderate diplopia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild dizziness
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Adverse Effects
Moderate dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Severe dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild anxiety
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Effects
Moderate anxiety
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Severe Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild vomiting
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Adverse Effects
Moderate vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Effects
Severe vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild shivering
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Effects
Mild Nausea
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Adverse Effects
Moderate Nausea
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Adverse Effects
Moderate shivering
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Effects
Severe Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild sedation
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Adverse Effects
Moderate sedation
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Effects
Severe sedation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild blurred vision
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Adverse Effects
Moderate blurred vision
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Severe blurred vision
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild diplopia
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Effects
Severe diplopia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Severe anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Mild pruritus
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Adverse Effects
Moderate pruritus
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Effects
Severe pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Euphoria
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Amnesia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Hallucinations
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Effects
Nystagmus
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and approximately 20, 40 and 100 minutes postpartumPopulation: Ketamine assays not performed and therefore no data collected
Assays of venous blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: In the first 2 days postpartumMorphine equivalents
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Total Opiate Consumption in Morphine Equivalents
|
88.6 Morphine Milligram Equivalents
Standard Deviation 35.6
|
68.4 Morphine Milligram Equivalents
Standard Deviation 63.7
|
67 Morphine Milligram Equivalents
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: At 2, 6, 24 and 48 hours after delivery and on postpartum days 21 and 42Surgical site pain on a numerical rating scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
24 hours postoperatively
|
3 units on a scale
Interval 0.0 to 7.0
|
4.571428571 units on a scale
Interval 0.0 to 9.0
|
2 units on a scale
Interval 0.0 to 3.0
|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
48 hours postoperatively
|
3.428571429 units on a scale
Interval 0.0 to 7.0
|
4.25 units on a scale
Interval 1.0 to 8.0
|
3.125 units on a scale
Interval 0.0 to 7.0
|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
2 hours postoperatively
|
2.86 units on a scale
Interval 0.0 to 9.0
|
2.1428571428571 units on a scale
Interval 0.0 to 8.0
|
2.5 units on a scale
Interval 0.0 to 6.0
|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
6 hours postoperatively
|
3 units on a scale
Interval 0.0 to 7.0
|
4.714285714 units on a scale
Interval 2.0 to 7.0
|
1.875 units on a scale
Interval 0.0 to 4.0
|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
21 days postoperatively
|
1 units on a scale
Interval 0.0 to 3.0
|
3.333333333 units on a scale
Interval 0.0 to 8.0
|
0.875 units on a scale
Interval 0.0 to 3.0
|
|
Surgical Site Pain: Numerical Rating Scale (NRS 0-10)
42 days postoperatively
|
0.6666666667 units on a scale
Interval 0.0 to 2.0
|
0.333333333 units on a scale
Interval 0.0 to 2.0
|
0.285714286 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: On postpartum days 1, 2, 21 and 42The EPDS is a validated measure of depressive symptoms in the postpartum period. The scale is scored between 0 - 30, a higher score represents greater depressive symptomatology. We report the study mean of each participant's mean EPDS score for their postpartum assessments
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Edinburgh Postpartum Depression Scale (EPDS)
Day 1
|
7.5 units on a scale
Interval 0.0 to 13.0
|
4.75 units on a scale
Interval 0.0 to 18.0
|
4.25 units on a scale
Interval 1.0 to 12.0
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Day 2
|
8.43 units on a scale
Interval 0.0 to 17.0
|
5.63 units on a scale
Interval 0.0 to 20.0
|
5.38 units on a scale
Interval 0.0 to 12.0
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Day 21
|
6.4 units on a scale
Interval 0.0 to 13.0
|
2.83 units on a scale
Interval 0.0 to 8.0
|
5.14 units on a scale
Interval 0.0 to 20.0
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Day 42
|
9.75 units on a scale
Interval 7.0 to 17.0
|
3.33 units on a scale
Interval 0.0 to 16.0
|
3.86 units on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: At 1 and 5 minutes after deliveryApgar score (0-10) comprised of an assessment of neonatal color, tone and crying. A higher score indicates healthier color, tone and crying.
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Apgar Scores
Apgar 1min
|
8 score on a scale
Standard Deviation 1.62
|
8 score on a scale
Standard Deviation 2.39
|
8 score on a scale
Standard Deviation 0.35
|
|
Apgar Scores
Apgar 5 min
|
9 score on a scale
Standard Deviation 1.83
|
9 score on a scale
Standard Deviation 1.16
|
9 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Postpartum day 1Incidence of admission
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Admission to NICU
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Postpartum days 1 and 2An indication of whether breastfeeding has been successfully established (Yes or No).
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
The Number of Participants Achieving Breastfeeding Success
Day 1
|
3 Participants
|
6 Participants
|
5 Participants
|
|
The Number of Participants Achieving Breastfeeding Success
Day 2
|
3 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursPrevalence of intraoperative hypertension as defined by number of participants with a systolic blood pressure greater than 140 mmHg
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Prevalence of Intraoperative Hypertension
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursPrevalence of intraoperative bradycardia, defined as number of participants with a heart rate of less than 40 bpm
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Prevalence of Intraoperative Bradycardia
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Intraoperative phase, approximately 2 hoursPrevalence of intraoperative tachycardia as defined by the number of participants with a heart rate greater than 110 bpm
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Prevalence of Intraoperative Tachycardia
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On day of surgery, and postpartum days 1, 2, 21 and 42Mean Anxiety in the postpartum. General Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21. Higher scores indicate more severe anxiety.
Outcome measures
| Measure |
Control
n=7 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 Participants
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
Postpartum Anxiety
Day 1
|
5.17 units on a scale
Interval 0.0 to 8.0
|
5.63 units on a scale
Interval 0.0 to 21.0
|
3.5 units on a scale
Interval 0.0 to 12.0
|
|
Postpartum Anxiety
Day 2
|
6 units on a scale
Interval 0.0 to 13.0
|
4.75 units on a scale
Interval 0.0 to 21.0
|
4.5 units on a scale
Interval 0.0 to 15.0
|
|
Postpartum Anxiety
Day 21
|
5.8 units on a scale
Interval 0.0 to 10.0
|
2.333333333 units on a scale
Interval 0.0 to 9.0
|
4.57 units on a scale
Interval 0.0 to 19.0
|
|
Postpartum Anxiety
Day 42
|
5.75 units on a scale
Interval 4.0 to 7.0
|
3.5 units on a scale
Interval 0.0 to 17.0
|
2.71 units on a scale
Interval 0.0 to 9.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Ketamine SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ketamine IVI
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=7 participants at risk
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine SC
n=8 participants at risk
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
Ketamine IVI
n=8 participants at risk
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
Control: Administration of 0.9% Sodium Chloride (N/S)
|
|---|---|---|---|
|
General disorders
Nausea
|
28.6%
2/7 • Number of events 2 • 42 days
|
25.0%
2/8 • Number of events 2 • 42 days
|
50.0%
4/8 • Number of events 4 • 42 days
|
|
General disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • 42 days
|
37.5%
3/8 • Number of events 3 • 42 days
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Shivering
|
42.9%
3/7 • Number of events 3 • 42 days
|
25.0%
2/8 • Number of events 2 • 42 days
|
0.00%
0/8 • 42 days
|
|
Surgical and medical procedures
Sedation
|
42.9%
3/7 • Number of events 3 • 42 days
|
12.5%
1/8 • Number of events 1 • 42 days
|
37.5%
3/8 • Number of events 3 • 42 days
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 1 • 42 days
|
12.5%
1/8 • Number of events 1 • 42 days
|
37.5%
3/8 • Number of events 3 • 42 days
|
|
Eye disorders
Diplopia
|
14.3%
1/7 • Number of events 1 • 42 days
|
0.00%
0/8 • 42 days
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • 42 days
|
12.5%
1/8 • Number of events 1 • 42 days
|
37.5%
3/8 • Number of events 3 • 42 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Number of events 2 • 42 days
|
50.0%
4/8 • Number of events 4 • 42 days
|
25.0%
2/8 • Number of events 2 • 42 days
|
Additional Information
Dr. David Monks
Washington University School of Medicine
Phone: 314-323-1845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place